A phase III study comparing preservative-free latanoprost eye drop emulsion with preserved latanoprost in open-angle glaucoma or ocular hypertension.

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dc.creatorBaudouin, Christophe
dc.creatorStalmans, Ingeborg
dc.creatorBourne, Rupert
dc.creatorLarrosa, Jose Manuel
dc.creatorSchmickler, Stefanie
dc.creatorSeleznev, Aleksey
dc.creatorOddone, Francesco
dc.creatorPhase III study group
dc.date2025-05-19T14:45:26Z
dc.date2025-06
dc.date2024-05-22
dc.date2025-05-19T14:45:25Z
dc.date.accessioned2026-08-03T02:44:44Z
dc.descriptionAcknowledgements: The contribution of Francesco Oddone to this work was partially supported by Fondazione Roma. We would like to thank Mourad Amrane and Dahlia Ismail for their contributions to the clinical study. The study was funded by Santen Oy. Medical writing support was provided by Carys Davies and Anna Boake of Syneos Health, UK, and was funded by Santen SA.
dc.descriptionFunder: Santen Oy
dc.descriptionFunder: Santen Oy and partially supported by Fondazione Roma.
dc.descriptionBACKGROUND/OBJECTIVES: To evaluate the efficacy and safety of preservative-free latanoprost eye drop emulsion in reducing intraocular pressure (IOP) versus preserved latanoprost in open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: A Phase III non-inferiority study randomised patients with OAG/OHT 1:1 to receive preservative-free latanoprost eye drop emulsion or preserved latanoprost. The primary efficacy endpoint was change from baseline in peak (9:00 A.M. ± 1 h) and trough (4:00 P.M. ± 1 h) IOP at Week 12 (non-inferiority margin: 95% confidence interval for treatment difference of ≤1.5 mmHg). Key secondary endpoints were change from baseline in corneal fluorescein staining (CFS) score and in ocular surface disease (OSD) average symptom score at Week 12 (in patients with baseline CFS ≥ 1 or OSD score > 0, respectively). RESULTS: Non-inferiority criteria for IOP-lowering were met. Least square (LS) mean (standard error [SE]) IOP change from baseline with preservative-free latanoprost eye drop emulsion (N = 193) versus preserved latanoprost (N = 193) at Week 12 was -8.8 (0.3) mmHg versus -8.2 (0.3) mmHg at peak (difference: -0.6 mmHg; nominal p = 0.023); -8.6 (0.2) mmHg versus -8.1 (0.3) mmHg at trough (difference: -0.5 mmHg; p = 0.080). LS mean change in CFS (SE) was -0.7 (0.07) with preservative-free latanoprost eye drop emulsion and -0.4 (0.08) with preserved latanoprost (nominal p < 0.001). LS mean change in OSD symptom score was -0.3 (0.1) with preservative-free latanoprost eye drop emulsion and -0.2 (0.1) with preserved latanoprost (nominal p = 0.090). CONCLUSIONS: Preservative-free latanoprost eye drop emulsion demonstrated non-inferior IOP-lowering efficacy compared with preserved latanoprost, and improved signs and symptoms of OSD.
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dc.identifier0950-222X
dc.identifiers41433-025-03646-z
dc.identifier3646
dc.identifierhttps://www.repository.cam.ac.uk/handle/1810/384297
dc.identifier1476-5454
dc.identifier.urihttps://repo.dare.co.zw/handle/123456789/168834
dc.languageen
dc.languageeng
dc.publisherSpringer Science and Business Media LLC
dc.publisherhttps://doi.org/10.1038/s41433-025-03646-z
dc.subjectAged
dc.subjectFemale
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectAntihypertensive Agents
dc.subjectEmulsions
dc.subjectGlaucoma, Open-Angle
dc.subjectIntraocular Pressure
dc.subjectLatanoprost
dc.subjectOcular Hypertension
dc.subjectOphthalmic Solutions
dc.subjectPreservatives, Pharmaceutical
dc.subjectTonometry, Ocular
dc.subjectTreatment Outcome
dc.titleA phase III study comparing preservative-free latanoprost eye drop emulsion with preserved latanoprost in open-angle glaucoma or ocular hypertension.
dc.typeArticle

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